510(k) Report

FDA applicant

Terraflex

Efrat 90962, IL1 decision1994–19940 recalls

FDA records 1 decision for Terraflex (Efrat 90962, IL) in 1994: 1 510(k) clearance. All are in product code DYN (Mouthpiece, Saliva Ejector). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Terraflex’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Terraflex since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Terraflex by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Terraflex’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DYNMouthpiece, Saliva Ejector1decision

What has FDA decided for it lately?

  • K940769Dentflex Displosable Dental Saliva EjectorTerraflex · 1994

The one decision as Terraflex →